"说明
Introduction"
"总概述：主要负责质量保证体系的正常运营与维护，确保质量相关的标准/法规在工厂的应用和更新，同时通过协调自查、官方审计和客户审计来确认工厂的合规性。
Overview: Responsible for the normal operation and maintenance of quality assurance system. Ensures the application of Quality standards in site as well as their update. And also verifies the site compliance by coordinating self inspection, and regulatory audit and client audits.
1、负责工厂偏差、变更控制、CAPA 、OOS/OOT/MDD的体系管理，包括行动项的指导和跟进，并提供相关信息和趋势分析。
Responsible for site deviation, change control, CAPA, OOS/OOT/MDD, system management, including the followup and guidance for action plan. As well as providing related information and trend analysis.
2、负责产品投诉的处理，协调工厂内外部审计，自查以及质量差距评估、产品召回、质量计划维护、质量系统评审、不良反应等合规性活动，并提供合规相关信息和趋势的分析。
Responsible for handling production complaint, coordinating internal/external audit, and the compliance related activities like gap assessment, production recall, quality plan maintenance and quality system management review, Adverse Drug Reaction. As well as providing information and trend analysis of site compliance.
3、负责维护工厂的文件体系，确保工厂文档记录的合规性以及质量保证团队中必要的文件起草与修订审核等。
Responsible for site document system maintenance, ensure the compliance of site documentation and the quality assurance team necessary document drafting and revision review.
4、负责维护工厂的培训体系，确保人员得到相应的培训并获得资质，如入职培训、岗前培训、年度培训。
Responsible for site training system maintenance, ensure that personnel are appropriately trained and qualified , such as induction training, pre-job training, annual training.
5、负责档案室GMP 文件的管理，包括文件的接收、归档、借阅、复印和扫描等。
Responsible for the archives room GMP documents management, including the documents receiving, archiving, lending, reading, copying and scanning.
6、负责法规指南监控与解读流程的运行与相关业务的开展。
Responsible for the operation of the monitoring and interpretation process of regulatory guidelines and the operation of related businesses;
7、负责组织审核产品生命周期内的质量风险评估、控制、信息交流和回顾评审等系统化过程。如风险评估报告的编号、起草（必要时）、审核以及后续的文档管理等。
Responsible for the systematic process of organizing and reviewing the quality risk assessment, control, and information communication throughout the product life cycle.Such as risk assessment report numbering, drafting (if necessary), review and subsequent document management.
8、负责所有物料相关事宜的质量保证， 以及仓库日常运作的质量监管， 确保工厂的物料、包材、产品和服务符合需求。如物料放行和供应商管理，仓库的定期巡检，印刷包材/标签的样张管理等。
Responsible for the quality assurance of material related activities, and monitoring warehouse routine operation. Ensure site material, packaging material, product and service meet the requirements.Such as material release and supplier management, periodic inspections of the warehouse, manual artwork management.
9、领导交代的其他任务等，如：必要时需临时支援团队内部现场QA和验证QA的部分工作。
The tasks assigned by the leader, etc. Such as temporary support for on-site QA and validation QA within the team as necessary."

"任职资格
Position qualifications"
"1.学历：本科及以上
2.专业：化学分析等相关专业
3.工作经验：5年以上药厂QA工作经验

1. Education: Bachelor degree or above
2. Major: Chemical analysis and other related majors
3. Work experience: more than 5 years of QA work experience in pharmaceutical factories
"